November 07, 2011

NY Times: Medical Experts on Guidelines Panels - Not Welcome?

Last week, the New York Times joined a long list of other media sources who have begun using ad hominem attacks on clinical practice guidelines and the physician-industry relationships, instead of objectively reporting the nature of these collaborations. Instead of focusing on the guideline panels themselves and the valuable work they produce in helping physicians better treat patients, authors who use ad hominem attacks, focus on panel members relationships with industry and make personal attacks on such relationships as “unethical.”

The reason why an ad hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of the claim being made (or the quality of the argument being made).”

Times Article

The Times article begins by taking issue with three federal panels that develop public health guidelines on the leading causes of cardiovascular disease — hypertension, cholesterol and obesity.

Before lying out any statistics about the improved care patients have seen over the past several decades in treating these diseases, the author instead chooses to first point out that “one potential conflict after another has surfaced among the members, with some receiving speakers’ fees from drug companies, others consulting for pay and others doing company-financed research.”

The article continues its ad hominem attack by noting that, “about 20 of the three panels’ members, including some co-chairmen, have been advised that they should not vote on crucial issues as they prepare to issue the health guidelines next year — because they are too closely connected to industries with a keen interest in the panels’ recommendations.”

But the article totally ignores significant evidence that physician-industry collaboration has improved treatment in cardiovascular disease is troubling. The author completely neglects to cite the fact that since 1970, the death rate from heart disease has dropped approximately 60%, that deaths from stroke are down 70% since 1970, and that the average life span of Americans increased from 69.7 years in 1960 to approximately 80 years in 2007. For every $1 spent on:

Moreover, a recent report from the Centers for Disease Control and Prevention (CDC) found that the prevalence of coronary heart disease decreased from 6.7% to 6.0%, a remarkable 10.9% drop from 2006-2010. Furthermore, a recent study of 55 million patients, published in the Journal of the American Medical Association (JAMA) found that from 1998-2008, the rate for hospital stays for heart failure fell from 2,845 hospitalizations per 100,000 Medicare beneficiaries to 2,007 per 100,000. If that rate had remain unchanged, it would have cost Medicare $4.1 billion. If not for declines in heart disease and stroke deaths, we would lose 1 million more Americans per year. The article explicitly acknowledged that the main causes for the decline were:

specialized pacemakers and

better use of ACE inhibitors that relax blood vessels,

diuretics that prevent fluid buildup,

digoxin that boosts heartbeat strength and

beta blockers that ease strain on the heart

Completely ignoring this clear evidence that physician-industry collaboration has significantly improved patient outcomes in cardiovascular disease and its many causes, the article continues its ad hominem attack by citing panels who were “so marred by charges of industry bias that the National Institutes of Health extensively heightened the scrutiny for individual panelists.”

But as the article acknowledges, “the decline in federal financing for medical research continued to pose problems, leaving many researchers to rely more heavily on private industry support.” And as one author noted, “Since most clinical research in America is paid for by industry, it is difficult to have deep expertise without having had at least some contact with industry.”

“Conflicts-of-interest?”

The Times attempted to get conflict-of-interest statements from NIH through a Freedom of Information Act request, but was denied because it was deemed an invasion of privacy and interference with the work. Instead, the Times examined journal articles, professional conference speakers and drug company disclosures.

The article cited finding several panel members working with industry, including Dr. Suzanne Oparil, co-chairwoman of the hypertension group, and Dr. Donna H. Ryan, co-chairwoman of the obesity panel, who each received money or reimbursements from at least eight companies.

Dr. Oparil, a medical professor at the University of Alabama, Birmingham and a female pioneer in the field of hypertension management, said she had been asked to help lead the group and would recuse herself from voting. “If they want me to leave, I’d be fine with that,” she said. “It would be very disruptive.”

She has received in the past industry financing for research and consulting and has been a member of speaker bureaus for companies.

Dr. Ryan, a professor at Louisiana State University and past president of the Obesity Society, a professional group, said she quit taking consulting payments from companies in 2008 and takes only travel expenses. “It’s impossible for me to be totally conflict-free,” she said.

The Institute of Medicine reports recommended that those with industry conflicts of interest should generally be excluded, or limited to “a distinct minority of the panel.”

The Times article noted that, “At least eight of the 19 members of the obesity panel have financial ties.”

GlaxoSmithKline, maker of Alli, an over-the-counter product, has made payments to four of them. Four have financial ties to Allergan, maker of the Lap-Band stomach device. One is paid to speak or advise 11 companies with obesity products. And others consult for companies like Nestlé or Weight Watchers. Dr. Ryan disputed the number of conflicts but would not elaborate. These relationships should be applauded not shamed.

The cholesterol panel includes seven professors with financial ties to drug makers, six without conflicts and three government experts, records indicate. Dr. Neil J. Stone of Northwestern University, chairman of the cholesterol panel, who was on speaker bureaus for nine companies, said, “I severed my ties with industry to take the job” of panel chairman.

A vice chairwoman of the panel, Dr. Jennifer G. Robinson of the University of Iowa, disclosed in May that she was taking research money from seven companies, including some top sellers of cholesterol pills. University of Iowa records show industry financing of more than $450,000 for research led by Dr. Robinson since the N.I.H. panel started work in 2008. Although Dr. Robinson has taken part in discussions on the panel, she said she would not vote on any issue before it.

Five of 17 members of the hypertension group have taken money from drug makers since it formed in 2008. “Our panel is about a third with some conflict of interest, but that is a vast improvement from the past,” said Dr. Paul A. James of the University of Iowa, a family doctor and co-chairman, who reports no industry financing. “Can it get better? Possibly. But there is a balancing act that must occur.”

The National Heart, Lung and Blood Institute of N.I.H., which governs the panels, hired outside contractors to compile and grade the science specifically to avoid bias. Panel members with industry ties are required to disclose them before speaking and to recuse themselves from voting, although N.I.H. officials say there is no penalty if anyone were to defy that self-imposed policy.

“You can’t have a panel with expertise in the area that doesn’t have some kind of conflicts,” said Dr. Denise Simons-Morton, who oversees the project. “In comparison to the previous way the guidelines were done, we’re taking a much more rigorous approach, a much more scientific approach, to minimize bias.”

Dr. Stone said, “We’re taking extraordinary measures to reduce any bias from potential conflicts of interest on a panel with tremendous expertise.”

Industry Critics

The Times article attempts to discredit the panelists because “at least eight members of the obesity panel, seven on the cholesterol panel and five on the hypertension panel are taking money in various forms from companies that could profit from their recommendations. The money ranges from small travel reimbursements to more than $400,000 for years of research.”

What is exactly wrong with being reimbursed at fair market value for conducting ethical and legal research for the purpose of advancing medicine and science all in the interest of improving patient care and outcomes?

Instead, the author chooses to quote his so called “experts,” the most prominent industry critics in the field, to support the notion that any such involvement of industry on panels creates the potential for “bias” or “conflict.”

For example, the author quotes, David J. Rothman, president of the Institute on Medicine as a Profession, a nonprofit center affiliated with Columbia University, who asserted that, “Consciously or not, they may well be making decisions that fit their funders, their payers and not the patient’s best interests.” “If you want the public to really believe in the guidelines, why not have a committee that is conflict-free?” he said.

But Dr. Rothman gives us no clue where to find qualified experts, with the necessary experience to sit on these panels and committees, who can adequately do the work. If Rothman thinks he can find the experts who are qualified, we would welcome that suggestion, as the Food and Drug Administration (FDA) is having extreme difficulty filling almost 1/3 of its seats on their advisory committees. And now, FDA officials, including Commissioner Hamburg and CDER Director Janet Woodcock, are heavily considering changing the conflict of interest rules because of the difficulty finding qualified experts.

The article also cited industry critic Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who stated that, the reason that recusing and disclosing “doesn’t work is because the process involves give-and-take.” “Even if you don’t make a formal vote, you can still have a huge influence over what happens in the process.”

But Dr. Nissen could not be more wrong, and that fact is supported by evidence. Another piece of evidence the article failed to mention is a study conducted in 2006 in JAMA, which examined a total of 221 meetings held by 16 FDA advisory committees. The researchers concluded that a weak relationship between certain types of conflicts and voting behaviors was detected, and that excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.

While industry critics would call for panel members who work with industry to be removed, which is clearly contrary to the evidence cited above, “Dr. Simons-Morton and Dr. Stone said they could not be expected to change membership on panels that began work in 2008 in order to meet Institute of Medicine recommendations that were not issued until 2009 and this year.”

Citing yet another industry critic, “Dr. Bernard Lo, a bioethicist at the University of California, San Francisco and lead author of the 2009 institute report, who said that panels should be as up to date on conflict of interest as they are on science to ensure the acceptance of their reports.” “Chairs or co-chairs should have no conflicts because of the great discretion they have shaping the agenda,” Dr. Lo said.

The lead writer on this year’s institute report, Dr. Sheldon Greenfield of the University of California, Irvine, said that if the panels could not follow the institute guidance strictly, “They’d better use our first rule: make it as visible and transparent as possible.”

Discussion

As Dr. R.W. Donnell noted, of the scores of guidelines in existence, only two have been associated with negative outcomes. The first, the AHA guidelines for CPR & emergency cardiac care, the flaw was well understood and was not related to industry influence. The second was the IDSA HCAP guidelines.

Moreover, last year, a final report from the Infectious Diseases Society of America (IDSA) revealed that the recommendations from a panel of experts making guidelines for Lyme disease were “medically and scientifically justified.” When the guidelines were released in 2006, some in Connecticut raised questions about panel members relationships with industry. IDSA agreed to appoint an independent review panel in 2010 to review the recommendations. The final report from the independent panel found that all of the 69 original IDSA recommendations were "medically and scientifically justified.” The vote was unanimous (8-0) for 68 out 69 of recommendations, and was 7-to-1 on the issue of chronic Lyme disease.

Richard N. Fogoros, M.D. noted that what this article and others using ad hominem attacks have demonstrated is a great paradigm shift regarding the appropriate relationship between physicians and industry. He noted that, until very recently, the American public, doctors, industry, and medical ethicists, thought about that relationship in a certain way, he called “Theory A:”

Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A, you believe that, because well-managed physician-industry relationships benefit humankind, these relationships are good. So, fundamentally, it’s the management and disclosure of these relationships which is at issue and the debate about conflicts of interest has traditionally been about where to draw the necessary limits. However, the New York Times article“points out that Theory A is no longer operative.”

He explained that, “The new thinking begins with the proposition that no amount of conflict of interest is acceptable, and all physician-industry ties should be prohibited.” He cited “one of the most prominent advocates of this new thinking, Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of conflicts of interest is not to have them at all.” For these voices, Theory A simply does not apply. Rather, they subscribe to Theory B:

The greed of medical industry creates excessive costs, and produces far more harm to society than good

Therefore, crippling these unholy alliances is critical to the interests of society.

“Underlying Theory B, is the proposition that medical progress is not good after all, but is the very thing that is driving up our healthcare costs, and so it must be stifled. A corollary of Theory B is that the government, through regulations and conflict of interest rules should cripple physician industry relationships and has a duty to do so.”

“Proponents of Theory B maintain that industry is concerned with profits rather than the public good, and conclude therefore that industry will always behave in ways that are counter to the interests of society. While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce to the collective. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.”

“Proponents of Theory B rarely say what their real goal is. To come out and say that their goal is to cripple the companies responsible for producing medical progress would not be expedient. So most of them still give lip service to Theory A. One must discern their real motives from their behavior.”

“Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who ought to use industry’s products, or when and how. That kind of information can only be managed by unbiased sources.”

This is the very thinking that produces the impetus for creating conflict of interest rules that ban physicians who work with industry from participating. Under Theory B, only “experts who are free of industry ties and who answer only to our beneficent, unbiased, completely objective government can say which products of industry are good and bad, and can manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed by whatever means are necessary.”

Ultimately, as the author notes, “it is obvious that the government is desperately biased when it comes to medical progress in general, and in particular when it comes to establishing “guidelines” for the use of expensive drugs and medical devices. But under Theory B there is no government bias. There is only industry bias. And when we purge the government panels of all industry bias, by definition we will have created perfect objectivity.”

If the government continues pushing its agenda to free guideline panels of members who work with industry, it will be “free to seed its panels only with members whose bias runs in their direction, as we have seen with several recent panels —i.e. using generic drugs, focusing on economics and costs, not patient outcomes.

Freedom from experts is not the answer. A principled expert with experience, in the end is good for patient care and should be a welcome addition to guidelines panels.

Comments

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"Freedom from experts is not the answer. A principled expert with experience, in the end is good for patient care and should be a welcome addition to guidelines panels."

Agreed. At the end of the day, it is impossible to get completely free from any potential conflicts of interest. The only way to do that is to select individuals who are so ignorant of medical trials altogether that their opinion on such would be next to worthless.